Proof-of-concept Study for a New Intraocular Lens, MODEL C0001

Status Completed

Clinical Trial Summary

This study is a 12-month, prospective, 2-arm (1 test & 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL. The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit. The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cataract

Clinical Trial Details

NCT number	NCT05036070
Study type	Interventional
Source	Johnson & Johnson Surgical Vision, Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 18, 2021
Completion date	April 24, 2024

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